JP5166208B2 - Sample analyzer, calibration method for sample analyzer, and computer program - Google Patents

Description

  The present invention relates to a sample analyzer, a calibration method for a sample analyzer, and a computer program.

  Conventionally, various sample analyzers such as a multi-item blood cell analyzer, a blood coagulation measuring device, an immune analyzer, a biochemical analyzer, and a urine analyzer are known. In these sample analyzers, the apparatus is periodically calibrated. In the calibration of the apparatus, prior to the measurement of the calibration sample, the same sample is measured a plurality of times, and it is confirmed that the variation in the analysis result is within a predetermined range.

Patent Document 1 describes a data processing apparatus in which a plurality of automatic analyzers are connected. The data processing apparatus described in Patent Document 1 aggregates measurement results of calibration samples in each automatic analyzer, and automatically performs calculation and calibration coefficient correction.
JP-A-6-308131

  However, in the data processing apparatus described in Patent Document 1, it is necessary to measure the same calibration sample with each of a plurality of automatic analyzers. If a calibrator is used as the calibration sample, the calibrator is very expensive, which increases the cost. Further, after calibrating one automatic analyzer, a sample unrelated to the calibration of the one automatic analyzer is measured as a calibration sample by each automatic analyzer, and the one automatic analyzer calibrated is measured. When the correlation process is performed, there is a problem that it is necessary to measure the sample in all automatic analyzers, and the sample is wasted.

  The present invention has been made in view of such circumstances, and the main object of the present invention is to reduce the cost for calibration of the sample analyzer as compared with the prior art and to reduce the number of samples used for calibration. An object of the present invention is to provide a sample analyzer, a method for calibrating a sample analyzer, and a computer program.

  In order to solve the above-described problems, a sample analyzer according to one aspect of the present invention is configured to perform first and second sample measurement units that measure a sample, and to measure samples in the first and second sample measurement units. An information processing unit that acquires each analysis result based on the first correction means for correcting the analysis result based on the measurement of the sample by the first sample measurement unit based on a first correction value. And second correction means for correcting the analysis result based on the measurement of the sample by the second sample measurement unit based on the second correction value, and analysis obtained when the first sample measurement unit measures the calibration sample. Using the result, the first calibration means for updating the first correction value and the variation of the plurality of analysis results obtained by measuring the same reproducibility confirmation sample a plurality of times by the second sample measurement unit The plurality of analysis results used in the reproducibility check for determining whether or not they are within a predetermined range and the analysis result based on the measurement by the first sample measurement unit of the sample for reproducibility check are the first calibration. And second calibration means for updating the second correction value using the corrected analysis result corrected by the first correction value updated by the means.

  In this aspect, the information processing unit determines whether or not variations in a plurality of analysis results obtained by measuring the reproducibility confirmation sample a plurality of times by the second sample measurement unit are within a predetermined range. It is preferable to further comprise a second sample measurement unit reproducibility confirmation means for discriminating.

  In the above aspect, the sample analyzer provides the reproducibility in order to supply the reproducibility confirmation sample to a transport unit that transports a sample, and the first sample measurement unit and the second sample measurement unit. Transport control means for controlling the transport unit so as to transport the confirmation sample to the first sample measurement unit and the second sample measurement unit, and the first sample measurement unit is transported by the transport unit. The reproducibility check sample is configured to be measured, and the second sample measurement unit is configured to measure the reproducibility check sample transported by the transport unit a plurality of times. It is preferable.

  In the above aspect, the transport control unit transports the reproducibility confirmation sample to the first sample measurement unit, and after the sample is supplied to the first sample measurement unit, the calibration sample is removed. The transport unit is controlled to be transported to the first sample measurement unit, and the first sample measurement unit measures the reproducibility confirmation sample transported by the transport unit a plurality of times. The calibration sample conveyed by the conveyance unit is measured, and the information processing unit is obtained by measuring the reproducibility confirmation sample a plurality of times by the first sample measurement unit. It is preferable to further include a first sample measurement unit reproducibility confirmation unit for determining whether or not the variation of the plurality of analysis results is within a predetermined range.

  Moreover, in the said aspect, it is preferable that the said information processing unit comprises the said conveyance control means.

  Further, in the above aspect, the information processing unit stores the analysis result of the sample, and the reproducibility confirmation by the second sample measurement unit from the plurality of analysis results stored in the storage unit. Receiving means for accepting selection of a plurality of analysis results of a sample for analysis, wherein the second calibration means selects the plurality of analysis results selected and the reproducibility confirmation sample by the first sample measurement unit. It is preferable that the second correction value is updated based on the analysis result.

  In the above aspect, the second calibration unit obtains an average value obtained by averaging a plurality of analysis results obtained by the second sample measurement unit measuring the reproducibility confirmation sample a plurality of times, The second correction value is configured to be updated based on an analysis result of the reproducibility confirmation sample by the first sample measurement unit and an average value of the analysis result by the second sample measurement unit. preferable.

  Moreover, in the said aspect, it is preferable that the said information processing unit is comprised so that the analysis result corrected by the said 2nd correction means based on the said 2nd correction value may be output.

  The sample analyzer calibration method according to one aspect of the present invention is a sample analyzer calibration method including a first sample measurement unit and a second sample measurement unit, and includes the first and second sample measurement units. Respectively, a step of acquiring an analysis result based on the measurement of the sample, a step of correcting an analysis result based on the measurement of the sample by the first sample measurement unit based on a first correction value, and a step of the second sample measurement unit. The first correction value is updated using the step of correcting the analysis result based on the measurement of the sample based on the second correction value, and the analysis result obtained when the first sample measurement unit measures the calibration sample. And whether or not the dispersion of a plurality of analysis results obtained by measuring the same reproducibility confirmation sample a plurality of times by the second sample measurement unit is within a predetermined range. After the correction, the plurality of analysis results used in the reproducibility check for determining the reproducibility and the analysis result based on the measurement by the first sample measurement unit of the reproducibility check sample are corrected by the updated first correction value. And updating the second correction value using the analysis result.

  A calibration method for a sample analyzer according to another aspect of the present invention is a calibration method for a sample analyzer including a first sample measurement unit and a second sample measurement unit, and is used for calibration by the first sample measurement unit. Measure the sample, calibrate the first sample measurement unit, and measure the same reproducibility confirmation sample multiple times by the second sample measurement unit, and the variation of the obtained multiple analysis results is within a predetermined range Determining the reproducibility confirmation sample by the calibrated first sample measurement unit, obtaining the analysis result of the reproducibility confirmation sample, and the first The second sample measurement based on the analysis result of the reproducibility check sample by the sample measurement unit and the analysis result of the reproducibility check sample by the second sample measurement unit Comprising the steps of: calibrating the knit, the.

  A computer program according to an aspect of the present invention is a computer program for causing a computer to calibrate a sample analyzer including a first sample measurement unit and a second sample measurement unit. And acquiring each of the analysis results based on the measurement of the sample of the second sample measurement unit, correcting the analysis result based on the measurement of the sample by the first sample measurement unit based on the first correction value, Correcting the analysis result based on the measurement of the sample by the second sample measurement unit based on the second correction value, and using the analysis result obtained when the first sample measurement unit measures the calibration sample, Updating the first correction value, and measuring the same reproducibility confirmation sample a plurality of times by the second sample measurement unit. Measurement of the plurality of analysis results used in the reproducibility check for determining whether or not variations of the plurality of analysis results obtained are within a predetermined range, and measurement of the reproducibility check sample by the first sample measurement unit The second correction value is updated using the post-correction analysis result obtained by correcting the analysis result based on the updated first correction value.

  According to the sample analyzer of the present invention, it is possible to reduce the cost for calibration of the sample analyzer compared to the prior art and to reduce the number of samples used for calibration.

  Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings.

  The present embodiment includes two measurement units, a first measurement unit and a second measurement unit, and an information processing unit communicatively connected to the first measurement unit and the second measurement unit. This is a sample analyzer that calibrates the second measurement unit using the reproducibility confirmation sample used for calibration.

[Sample analyzer configuration]
1A and 1B are perspective views showing the overall configuration of the sample analyzer according to the present embodiment. The sample analyzer 1 according to the present embodiment is a multi-item blood cell analyzer that detects white blood cells, red blood cells, platelets, and the like from blood cells contained in a blood sample and counts each blood cell. As shown in FIGS. 1A and 1B, the sample analyzer 1 includes a first measurement unit 2, a second measurement unit 3, and a sample transport arranged on the front side of the first measurement unit 2 and the second measurement unit 3. A unit 4, a first measurement unit 2, a second measurement unit 3, and an information processing unit 5 capable of controlling the sample transport unit 4 are provided.

  FIG. 2 is a perspective view showing an external appearance of a sample container that contains a sample, and FIG. 3 is a perspective view showing an external appearance of a sample rack that holds a plurality of sample containers. As shown in FIG. 2, the sample container T has a tubular shape, and an upper end is opened. A blood sample collected from the patient is housed inside, and the opening at the upper end is sealed by a lid CP. The specimen container T is made of translucent glass or synthetic resin, and an internal blood specimen can be visually recognized. A barcode label BL1 is attached to the side surface of the sample container T. A barcode indicating the sample ID is printed on the barcode label BL1. Moving to FIG. 3, the sample rack L can hold ten specimen containers T side by side. In the sample rack L, each sample container T is held in a vertical state (standing position). A barcode label BL2 is attached to the side surface of the sample rack L. A barcode indicating the rack ID is printed on the barcode label BL2.

<Configuration of measurement unit>
FIG. 4 is a block diagram showing the configuration of the measurement unit. As shown in FIG. 4, the first measurement unit 2 includes a sample suction unit 21 that sucks blood as a sample from a sample container (collection tube) T, and a measurement sample used for measurement from the blood sucked by the sample suction unit 21. A sample preparation unit 22 that prepares the blood sample and a detection unit 23 that detects blood cells from the measurement sample prepared by the sample preparation unit 22. Further, the first measurement unit 2 has an inlet 24 (see FIG. 5) for taking the sample container T accommodated in the sample rack L conveyed by the rack conveyance unit 43 of the sample conveyance unit 4 into the first measurement unit 2. 1A and FIG. 1B) and a sample container transport unit 25 that takes the sample container T from the sample rack L into the first measurement unit 2 and transports the sample container T to the suction position by the sample suction unit 21. ing. Further, as shown in FIGS. 1A and 1B, on the outer surfaces of the first measurement unit 2 and the second measurement unit 3, the sample set section open / close buttons 27 and 37, the priority sample measurement start buttons 28 and 38, respectively. Is provided.

  As shown in FIG. 4, a suction tube (not shown) is provided at the distal end portion of the sample suction portion 21. The sample aspirating unit 21 is movable in the vertical direction. When the sample aspirating unit 21 is moved downward, the aspirating tube penetrates the lid CP of the sample container T conveyed to the aspirating position, and aspirates the blood inside. Is configured to do.

  The sample preparation unit 22 includes a plurality of reaction chambers (not shown). The sample preparation unit 22 is connected to a reagent container (not shown) and can supply reagents such as a staining reagent, a hemolytic agent, and a diluent to the reaction chamber. The sample preparation unit 22 is also connected to the suction tube of the sample suction unit 21, and can supply the blood sample sucked by the suction tube to the reaction chamber. The sample preparation unit 22 mixes and agitates the specimen and the reagent in the reaction chamber to prepare a sample (measurement sample) for measurement by the detection unit 23.

  The detection unit 23 can perform RBC (red blood cell) detection and PLT (platelet) detection by a sheath flow DC detection method. In detection of RBC and PLT by this sheath flow DC detection method, a measurement sample in which a specimen and a diluent are mixed is measured, and the information processing unit 5 analyzes and processes the obtained measurement data. RBC and PLT measurements are made. The detection unit 23 can perform HGB (hemoglobin) detection by the SLS-hemoglobin method, and includes WBC (leukocyte), NEUT (neutrophil), LYMPH (lymphocyte), EO (eosinophil), BASO (basophil) and MONO (monocyte) can be detected by a flow cytometry method using a semiconductor laser. In this detection unit 23, the detection method is different between five types of white blood cells, that is, detection of WBC without detection of NEUT, LYMPH, EO, BASO, and MONO, and detection of WBC with five types of white blood cells. . In the detection of WBC without the classification of leukocytes, the measurement sample obtained by mixing the specimen, the hemolytic agent, and the diluent is measured, and the information processing unit 5 analyzes the measurement data obtained thereby. The WBC is measured by. On the other hand, in the detection of WBC accompanied by five leukocytes classification, a measurement sample in which a staining reagent, a hemolyzing agent, and a diluent are mixed is measured, and the information processing unit 5 performs analysis processing on the measurement data obtained thereby. Thus, NEUT, LYMPH, EO, BASO, MONO, and WBC are measured.

  FIG. 5 shows a schematic configuration of an optical detection unit for detecting WBC / DIFF (white blood cell 5 classification) provided in the detection unit 23. The optical detection unit 23a measures a measurement sample by feeding a measurement sample into the flow cell 231, generating a liquid flow in the flow cell 231, and irradiating a blood cell included in the liquid flow passing through the flow cell 231 with semiconductor laser light. A sheath flow system 232, a beam spot forming system 233, a forward scattered light receiving system 234, a side scattered light receiving system 235, and a side fluorescent light receiving system 236.

  The sheath flow system 232 improves the accuracy and reproducibility of the blood cell count by flowing through the flow cell 231 in a state where the blood cells are arranged in a row with the sample wrapped in the sheath liquid. The beam spot system 233 is configured such that the light irradiated from the semiconductor laser 237 is irradiated to the flow cell 231 through the collimator lens 238 and the condenser lens 239. The beam spot system 233 also includes a beam stopper 240.

  The forward scattered light receiving system 234 is configured to collect forward scattered light by the front condenser lens 241 and receive light passing through the pinhole 242 by a photodiode (forward scattered light receiving unit) 243. Yes.

  The side scattered light receiving system 235 collects the scattered light to the side by the side condensing lens 244 and reflects a part of the light by the dichroic mirror 245, and a photodiode (side scattered light receiving unit) 246. Is configured to receive light.

  Light scattering is a phenomenon that occurs when particles such as blood cells exist as obstacles in the traveling direction of light and the light changes its traveling direction. By detecting this scattered light, information on the size and material of the particles can be obtained. In particular, information on the size of the particles (blood cells) can be obtained from the forward scattered light. Moreover, the information inside the particles can be obtained from the side scattered light. When blood cells are irradiated with laser light, the side scattered light intensity depends on the complexity of the cell (the shape, size, density, and amount of granules). Therefore, by utilizing this characteristic of the side scattered light intensity, measurement of the classification of white blood cells and other measurements can be performed.

  The side fluorescent light receiving system 236 is configured such that the light transmitted through the dichroic mirror 245 is further passed through the spectral filter 247 and received by the photomultiplier (fluorescent light receiving unit) 248.

  When a fluorescent material such as a stained blood cell is irradiated with light, light having a wavelength longer than the wavelength of the irradiated light is emitted. The intensity of fluorescence becomes stronger if it is well stained, and information on the degree of staining of blood cells can be obtained by measuring the intensity of fluorescence. Therefore, the measurement of white blood cell classification and other measurements can be performed based on the difference in (side) fluorescence intensity.

  Returning to FIG. 4, the configuration of the sample container transport unit 25 will be described. The sample container transport unit 25 includes a hand unit 25a that can hold the sample container T. The hand portion 25a includes a pair of gripping members disposed to face each other, and the gripping members can be moved toward and away from each other. The specimen container T can be gripped by bringing the gripping members close together with the specimen container T sandwiched therebetween. Further, the sample container transport unit 25 can move the hand unit 25a in the vertical direction and the front-rear direction (Y direction), and can swing the hand unit 25a. Thereby, the sample container T accommodated in the sample rack L and positioned at the first sample supply position 43a is gripped by the hand unit 25a, and in this state, the sample container T is moved from the sample rack L by moving the hand unit 25a upward. The sample in the sample container T can be agitated by extracting and swinging the hand portion 25a.

  The sample container transport unit 25 includes a sample container setting unit 25b having a hole part into which the sample container T can be inserted. The sample container T gripped by the hand unit 25a described above is moved after the stirring is completed, and the gripped sample container T is inserted into the hole of the sample container setting unit 25b. Thereafter, by separating the gripping member, the sample container T is released from the hand unit 25a, and the sample container T is set in the sample container setting unit 25b. The sample container setting unit 25b can be moved horizontally in the Y direction by the power of a stepping motor (not shown).

  Inside the first measurement unit 2, a barcode reading unit 26 is provided. The sample container setting unit 25 b is movable to a barcode reading position 26 a near the barcode reading unit 26 and a suction position 21 a by the sample suction unit 21. When the sample container setting unit 25b moves to the barcode reading position 26a, the set sample container T is horizontally rotated by a rotation mechanism (not shown), and the sample barcode is read by the barcode reading unit 26. Thereby, even when the barcode label BL1 of the sample container T is located on the opposite side with respect to the barcode reading unit 26, the barcode label BL1 is directed to the barcode reading unit 26 by rotating the sample container T. It is possible to cause the barcode reading unit 26 to read the sample barcode. Further, when the sample container setting unit 25b moves to the aspiration position, the sample is aspirated from the set sample container T by the sample aspiration unit 21.

  Further, the sample container setting unit 25b is movable to the priority sample setting position shown in FIG. 4 so as to protrude forward as shown in FIG. 1B. The sample set section open / close button 27 is configured to be pressed by an operator or a service person when performing priority sample measurement. When the sample setting section open / close button 27 is pressed, the sample container setting section 25b moves forward to the priority sample setting position. Further, the priority sample measurement start button 28 is configured to be pressed by an operator or a service person, and when the priority sample measurement start button 28 is pressed, the sample container setting unit 25b in which the priority sample is set is the first one. It is taken into the measurement unit 2 and measurement is started.

  The configuration of the second measurement unit 3 is the same as that of the first measurement unit 2, and the second measurement unit 3 is used for measurement from the sample aspirating unit 31 and blood aspirated by the sample aspirating unit 31. A sample preparation unit 32 that prepares a sample and a detection unit 33 that detects blood cells from the measurement sample prepared by the sample preparation unit 32 are provided. Further, the second measurement unit 3 has an intake port 34 (see FIG. 5) for taking the sample container T accommodated in the sample rack L conveyed by the rack conveyance unit 43 of the sample conveyance unit 4 into the second measurement unit 3. 1A and FIG. 1B) and a sample container transport unit 35 that takes the sample container T from the sample rack L into the second measurement unit 3 and transports the sample container T to the suction position by the sample suction unit 31. ing. The configuration of the sample aspirating unit 31, the sample preparing unit 32, the detecting unit 33, the intake port 34, the sample container transporting unit 35, and the barcode reading unit 36 includes the sample aspirating unit 21, the sample preparing unit 22, the detecting unit 23, Since it is the same as that of the structure of the intake port 24 and the sample container conveyance part 25, the description is abbreviate | omitted.

<Configuration of sample transport unit>
Next, the configuration of the sample transport unit 4 will be described. As shown in FIGS. 1A and 1B, a sample transport unit 4 is disposed in front of the first measurement unit 2 and the second measurement unit 3 of the sample analyzer 1. The sample transport unit 4 can transport the sample rack L in order to supply the sample to the first measurement unit 2 and the second measurement unit 3.

  FIG. 6 is a plan view showing the configuration of the sample transport unit 4. As shown in FIG. 6, the sample transport unit 4 has a pre-analysis rack holding unit 41 that can temporarily hold a plurality of sample racks L that hold a sample container T that holds a sample before analysis. A post-analysis rack holding unit 42 capable of temporarily holding a plurality of sample racks L holding a sample container T from which the sample has been aspirated by the first measurement unit 2 or the second measurement unit 3, and a sample In order to supply to the first measurement unit 2 or the second measurement unit 3, the sample rack L is linearly moved horizontally in the direction of the arrow X in the figure, and the sample rack L received from the pre-analysis rack holding unit 41 is held after the analysis. And a rack transport unit 43 for transporting to the unit 42.

  The pre-analysis rack holding unit 41 has a quadrangular shape in plan view, and its width is slightly larger than the width of the sample rack L. The pre-analysis rack holder 41 is formed one step lower than the surrounding surface, and the pre-analysis sample rack L is placed on the upper surface thereof. Further, from both side surfaces of the pre-analysis rack holding portion 41, rack feeding portions 41b are provided so as to protrude inward. The rack feeding portion 41b protrudes to engage with the sample rack L, and in this state, the sample rack L is transferred rearward by moving backward (in the direction approaching the rack transporting portion 43). The rack feeding unit 41b is configured to be drivable by a stepping motor (not shown) provided below the pre-analysis rack holding unit 41.

  As shown in FIG. 6, the rack transport unit 43 can transport the sample rack L transferred by the pre-analysis rack holding unit 41 in the X direction. In order to supply the sample to the first sample supply position 43a and the second measurement unit 3 for supplying the sample to the first measurement unit 2 shown in FIG. The second specimen supply position 43b exists. Returning to FIG. 4, the sample transport unit 4 is controlled by the information processing unit 5, and when the sample is transported to the first sample supply position 43a or the second sample supply position 43b, the hand unit 25a of the corresponding measurement unit or The sample container L is transported until the sample container T is returned to the sample rack L by holding the sample container T to which the sample 35a is transported and removing the sample container T from the sample rack L. Wait. Thus, the hand unit 25a or 35a can reliably take out the sample container T from the sample rack L while the sample container T is stopped at the first sample supply position 43a or the second sample supply position 43b. is there. Furthermore, the rack transport unit 43 can transport the sample rack L so as to transport the sample container T to the sample container detection position 43c.

  Further, moving to FIG. 6, the rack transport unit 43 has two belts, a first belt 431 and a second belt 432, which can operate independently. In addition, the width b1 of the first belt 431 and the second belt 432 in the arrow Y direction is less than half the width B of the sample rack L in the arrow Y direction. The first belt 431 and the second belt 432 are arranged in parallel so as not to protrude from the width B of the sample rack L when the rack transport unit 43 transports the sample rack L. FIG. 7 is a front view showing the configuration of the first belt 431, and FIG. 8 is a front view showing the configuration of the second belt 432. As shown in FIGS. 7 and 8, the first belt 431 and the second belt 432 are each formed in an annular shape, the first belt 431 is disposed so as to surround the rollers 431a to 431c, and the second belt 432 is It arrange | positions so that the rollers 432a-432c may be surrounded. Further, the outer periphery of the first belt 431 is provided with two projecting pieces 431d having an inner width w1 slightly larger (for example, 1 mm) than the width W in the X direction of the sample rack L. Similarly, As shown in FIG. 8, two projecting pieces 432 d are provided on the outer periphery of the second belt 432 so as to have an inner width w <b> 2 that is approximately the same as the inner width w <b> 1. The first belt 431 moves the outer periphery of the rollers 431a to 431c by a stepping motor (not shown) while holding the sample rack L inside the two protruding pieces 431d, thereby moving the sample rack L to the arrow X. Configured to move in the direction. The second belt 432 moves the outer periphery of the rollers 432a to 432c by a stepping motor (not shown) while holding the sample rack L inside the two protruding pieces 432d, thereby moving the sample rack L to the arrow X. Configured to move in the direction. The first belt 431 and the second belt 432 are configured to be able to transfer the sample rack L independently of each other.

  Returning to FIG. 4, the sample container sensor 44 is a contact-type sensor, and includes a goodwill-shaped contact piece, a light emitting element that emits light, and a light receiving element (not shown). The specimen container sensor 44 is bent when the contact piece comes into contact with the object to be detected, and as a result, the light emitted from the light emitting element is reflected by the contact piece and enters the light receiving element. Yes. As a result, when the sample container T to be detected housed in the sample rack L passes below the sample container sensor 44, the contact piece is bent by the sample container T, and the sample container T can be detected. .

  A rack delivery section 45 is arranged so as to face a post-analysis rack holding section 42 to be described later with the rack transport section 43 interposed therebetween. The rack delivery unit 45 is configured to linearly move horizontally in the arrow Y direction by a driving force of a stepping motor (not shown). Thus, when the sample rack L is transported to a position 451 between the after-analysis rack holding unit 42 and the rack sending unit 45 (hereinafter referred to as “after-analysis rack sending position”), the rack sending unit 45 is analyzed. By moving to the rear rack holding unit 42 side, the sample rack L can be pushed and moved into the post-analysis rack holding unit 42.

  The post-analysis rack holding portion 42 has a quadrangular shape in plan view, and its width is slightly larger than the width of the sample rack L. The post-analysis rack holder 42 is formed one step lower than the surrounding surface, and the sample rack L that has been analyzed is placed on the upper surface thereof. The post-analysis rack holding unit 42 is connected to the rack transport unit 43, and the sample rack L is sent from the rack transport unit 43 by the rack delivery unit 45 as described above.

  With the above-described configuration, the sample transport unit 4 transfers the sample rack L placed on the pre-analysis rack holding unit 41 to the rack transport unit 43 and further transports it by the rack transport unit 43. The specimen can be supplied to the first measurement unit 2 or the second measurement unit 3. Further, the sample rack L containing the sample that has been aspirated is transferred to the post-analysis rack delivery position (not shown) by the rack transport unit 43 and sent to the post-analysis rack holding unit 42 by the rack delivery unit 45. The In the case where a plurality of sample racks L are placed on the pre-analysis rack holding unit 41, the sample racks L that contain the samples for which analysis has been completed are successively sent to the post-analysis rack holding unit 42 by the rack sending unit 45, The plurality of sample racks L are stored in the post-analysis rack holding unit 42.

<Configuration of information processing unit>
Next, the configuration of the information processing unit 5 will be described. The information processing unit 5 is configured by a computer. FIG. 9 is a block diagram showing a configuration of the information processing unit 5. The information processing unit 5 is realized by a computer 5a. As shown in FIG. 9, the computer 5 a includes a main body 51, an image display unit 52, and an input unit 53. The main body 51 includes a CPU 51a, ROM 51b, RAM 51c, hard disk 51d, reading device 51e, input / output interface 51f, communication interface 51g, and image output interface 51h. The CPU 51a, ROM 51b, RAM 51c, hard disk 51d, reading device 51e, input The output interface 51f, the communication interface 51g, and the image output interface 51h are connected by a bus 51j.

  The CPU 51a can execute a computer program loaded in the RAM 51c. Then, the CPU 5a executes the computer program 54a for sample analysis and control of the first measurement unit 2, the second measurement unit 3, and the sample transport unit 4 as will be described later, so that the computer 5a becomes the information processing unit 5. Function.

  The ROM 51b is configured by a mask ROM, PROM, EPROM, EEPROM, or the like, and stores a computer program executed by the CPU 51a, data used for the same, and the like.

  The RAM 51c is configured by SRAM, DRAM, or the like. The RAM 51c is used for reading the computer program 54a recorded on the hard disk 51d. Further, when the CPU 51a executes a computer program, it is used as a work area for the CPU 51a.

  The hard disk 51d is installed with various computer programs to be executed by the CPU 51a, such as an operating system and application programs, and data used for executing the computer programs. A computer program 54a described later is also installed in the hard disk 51d.

  Further, the hard disk 51d corrects the first correction data D1 for correcting the analysis result generated from the measurement data of the first measurement unit 2 and the analysis result generated from the measurement data of the second measurement unit 2. Second correction data D2 is stored.

  The reading device 51e is configured by a flexible disk drive, a CD-ROM drive, a DVD-ROM drive, or the like, and can read a computer program or data recorded on the portable recording medium 54. The portable recording medium 54 stores a computer program 54a for causing the computer to function as the information processing unit 5. The computer 5a reads the computer program 54a from the portable recording medium 54, and the computer program 54a. Can be installed on the hard disk 51d.

  The computer program 54a is not only provided by the portable recording medium 54, but also from an external device that is communicably connected to the computer 5a via an electric communication line (whether wired or wireless). It is also possible to provide through. For example, the computer program 54a is stored in the hard disk of a server computer on the Internet. The computer 5a can access the server computer, download the computer program, and install it on the hard disk 51d. is there.

  The hard disk 51d is installed with a multitask operating system such as Windows (registered trademark) manufactured and sold by Microsoft Corporation. In the following description, it is assumed that the computer program 54a according to the present embodiment operates on the operating system.

  The input / output interface 51f is, for example, a serial interface such as USB, IEEE1394, or RS-232C, a parallel interface such as SCSI, IDE, or IEEE1284, and an analog interface including a D / A converter, an A / D converter, or the like. It is configured. An input unit 53 including a keyboard and a mouse is connected to the input / output interface 51f, and the user can input data to the computer 5a by using the input unit 53. The input / output interface 51 f is connected to the first measurement unit 2, the second measurement unit 3, and the sample transport unit 4. As a result, the information processing unit 5 can control each of the first measurement unit 2, the second measurement unit 3, and the sample transport unit 4.

  The communication interface 51g is an Ethernet (registered trademark) interface. The communication interface 51g is connected to a host computer (not shown) via a LAN. The computer 5a can transmit and receive data to and from the host computer connected to the LAN using a predetermined communication protocol through the communication interface 51g.

  The image output interface 51h is connected to an image display unit 52 constituted by an LCD, a CRT, or the like, and outputs a video signal corresponding to the image data given from the CPU 51a to the image display unit 52. The image display unit 52 displays an image (screen) according to the input video signal.

[Operation of Sample Analyzer 1]
Hereinafter, the operation of the sample analyzer 1 according to the present embodiment will be described.

<Automatic calibration operation>
First, an automatic calibration operation in which the sample analyzer 1 according to the present embodiment automatically calibrates the first measurement unit 2 and the second measurement unit 3 will be described. In this automatic calibration operation, a sample rack L in which a calibrator specimen container T and a specimen container T for reproducibility confirmation, which is a normal specimen, are respectively inserted at predetermined positions (holding position 1 and holding position 2 in this embodiment). The reproducibility confirmation sample confirms the reproducibility of the analysis result of the first measurement unit 2 before calibration, the calibrator calibrates the first measurement unit 2, and the reproducibility confirmation sample before calibration. The reproducibility of the analysis result of the second measurement unit 2 is confirmed, and a series of operations for calibrating the second measurement unit 3 are automatically performed. The calibrator is a sample whose component concentration is known, and by determining the correction value (correction data) of the analysis result so that the numerical value of the analysis result of the calibrator matches this concentration (hereinafter referred to as “reference concentration”), The measurement unit is calibrated. A normal sample is usually used as a sample for reproducibility confirmation.

  FIG. 10 is a diagram for explaining the outline of the procedure of the automatic calibration operation of the sample analyzer 1. As shown in the figure, in the automatic calibration operation of the sample analyzer 1 according to the present embodiment, first, the same sample A is measured five times continuously by the first measurement unit 2, and the five measurements are performed. It is confirmed (reproducibility confirmation) whether the variation in the analysis results falls within a predetermined range. Subsequently, the reference concentration of the calibrator is input to the sample analyzer 1, the calibrator is measured five times by the first measurement unit 2, and the correction value of the first measurement unit 2 is calculated from the analysis result of these calibrators and the reference concentration. Is done. Thereafter, the sample A is measured once again by the first measurement unit 2 and the analysis result based on the new correction value is calculated. Subsequently, the specimen A is measured five times by the second measurement unit 3, and it is confirmed whether the variation in the analysis result by the five measurements falls within a predetermined range. Thus, reproducibility confirmation of the analysis result of the second measurement unit 3 is performed. Next, an analysis result obtained by measuring the sample A of the first measurement unit 2 after calculating the correction value is set as a calibration target value (reference concentration) of the second measurement unit 3. The above-mentioned analysis results of the five measurements of the specimen A are read from the hard disk 51d, and the correction value of the second measurement unit 3 is calculated from these analysis results and the target value. The above is the outline of the procedure of the automatic calibration operation.

  Next, the automatic calibration operation of the sample analyzer 1 will be described in detail. FIG. 11 is a flowchart showing the processing flow of the CPU 51a in the automatic calibration operation of the sample analyzer 1. The operator inserts the sample container T containing the calibrator into the holding position 1 of the sample rack L, inserts the sample container T containing the human blood reproducibility confirmation sample into the holding position 2, and the pre-analysis rack holding unit 41. In this state, the operator operates the input unit 53 to instruct the information processing unit 5 to execute an automatic calibration operation. The computer program 54a executed by the CPU 51a of the information processing unit 5 is an event-driven program. When an event for receiving an instruction to execute an automatic calibration operation occurs in the CPU 51a (step S1), the process of step S2 is called. .

  In step S2, the CPU 51a displays a reference density input screen (not shown) of the calibrator (step S2). This screen is provided with an input area in which the reference concentration of the calibrator can be input. The operator operates the input unit 53 to input the reference concentration described in the calibrator packaging box or the like to the information processing unit 5. input. When an event for accepting the input of the reference density occurs (step S3), the CPU 51a stores the reference density in the hard disk 51d (step S4). Further, the CPU 51a performs the reproducibility check operation of the first measurement unit 2 that measures the reproducibility check sample by the first measurement unit 2 (step S5), and then measures the calibrator by the first measurement unit 2. The calibration operation of one measurement unit 2 is executed (step S6), and then the post-calibration measurement operation for measuring the sample for reproducibility confirmation by the first measurement unit 2 is executed (step S7). Next, the CPU 51a executes the calibration operation of the second measurement unit 3 that measures the reproducibility confirmation sample by the second measurement unit 3 (step S8), and thereafter ends the process.

  Hereinafter, the reproducibility check operation of the first measurement unit 2 will be described in detail. The reproducibility check operation of the first measurement unit 2 measures the reproducibility check sample before the calibration of the first measurement unit 2 in order to confirm the reproducibility of the analysis result before the calibration of the first measurement unit 2, This is an operation for acquiring the analysis result of the sample for reproducibility confirmation. FIG. 12 is a flowchart showing the flow of the reproducibility check operation of the first measurement unit 2. First, the CPU 51a controls the sample transport unit 4 to transport the sample rack L by the pre-analysis rack holding unit 41, and then transports the sample rack L on the rack transport unit 43 to hold the sample rack L. 2, that is, the specimen container T containing the specimen for reproducibility confirmation is transported to the first specimen supply position 43a (step S51).

  Next, the CPU 51a executes a first sample taking process for taking a sample from the sample container T at the first sample supply position 43a into the first measurement unit 2 (step S52). FIG. 13 is a flowchart showing the procedure of the first sample taking process by the CPU 51a of the information processing unit 5. First, the CPU 51a controls the sample container transport unit 25, extracts the sample container T at the first sample supply position 43a from the sample rack L (step S101), and controls the hand unit 25a to swing the sample container T. The sample inside is agitated (step S102). Next, the CPU 51a controls the hand unit 25a to set the sample container T in the sample container setting unit 25b (step S103), and further controls the sample container transport unit 25 to transport the sample container T to the suction position. (Step S104). After completing the process of step S104, the CPU 51a returns the process to the call address of the first sample taking process.

  Returning to FIG. 12, after the first sample taking process S <b> 52 is completed, the CPU 51 a sets 1 to the variable i indicating the number of measurements (step S <b> 53), and the first sample is measured by the first measurement unit 2. An analysis process is executed (step S54).

  FIG. 14 is a flowchart showing the procedure of the first sample analysis process performed by the CPU 51a of the information processing unit 5. The CPU 51a controls the sample aspirating unit 21, and aspirates an amount of sample necessary for measurement from the sample container T (step S111). After the sample has been aspirated, the CPU 51a controls the sample preparation unit 22 to prepare a measurement sample (step S112), supplies the measurement sample to the detection unit 23, and measures the sample by the detection unit 23. This is performed (step S113). Thereby, the CPU 51a acquires measurement data output from the detection unit 23. Thereafter, the CPU 51a executes a cleaning operation for cleaning the flow path or reaction chamber used for the measurement (step S114).

  Further, the CPU 51a executes an analysis process of the measurement data (step S115), and obtains an analysis result including numerical values of RBC, PLT, HGB, WBC, NEUT, LYMPH, EO, BASO, and MONO. Next, the CPU 51a corrects the correction data stored in the hard disk 51d (first correction data D1 in the case of measurement data of the first measurement unit 2; second correction data D2 in the case of measurement data of the second measurement unit 3). )) To correct the analysis result (step S116). The corrected analysis result data is stored in the hard disk 51d (step S117). After completing the process of step S117, the CPU 51a returns the process to the calling address of the first sample analysis process.

  Returning to FIG. 12, after the first sample analysis process S54 is completed, the CPU 51a determines whether i is 5 or more (step S55). If i is less than 5 (NO in step S55), CPU 51a increments i by 1 (step S56), and returns the process to step S54. Thereby, the sample for reproducibility confirmation is measured five times by the first measurement unit 2.

  When i is 5 or more in step S55 (YES in step S55), the CPU 51a reads the analysis result of the sample for reproducibility confirmation obtained by five measurements from the hard disk 51d, and the variation of the five analysis results is predetermined. It is determined whether or not it is within a range, that is, whether or not the difference between the minimum value and the maximum value of the five analysis results is within a predetermined range (step S57). If the variation of the five analysis results exceeds the predetermined range (NO in step S57), since the first measurement unit 2 is estimated to be abnormal, the CPU 51a displays an abnormality warning screen on the image display unit 52 ( Step S58), the process is terminated.

  On the other hand, when the variation of the five analysis results is within the predetermined range in step S57 (YES in step S57), the CPU 51a calculates an average value of these analysis results and stores it in the hard disk 51d (step S59). Thereafter, the CPU 51a controls the sample container transport unit 25 to return the sample container T containing the sample for reproducibility confirmation to the sample rack L (step S510), and the call address for the reproducibility confirmation operation of the first measurement unit 2 Return processing to.

  After the reproducibility check operation of the first measurement unit 2, the calibration operation (step S6) of the first measurement unit 2 is executed. Hereinafter, the calibration operation of the first measurement unit 2 will be described in detail. The calibration operation of the first measurement unit 2 is an operation of measuring the calibrator by the first measurement unit 2 and updating the first correction data D1 used for correcting the analysis result obtained from the measurement result by the first measurement unit 2. It is.

  FIG. 15 is a flowchart showing the flow of the calibration operation of the first measurement unit 2. First, the CPU 51a controls the sample transport unit 4 so that the sample rack L is transported on the rack transport unit 43, and the holding position 1 of the sample rack L, that is, the sample container T containing the calibrator is moved to the first sample. Transport to the supply position 43a (step S601). Next, the CPU 51a executes a first sample taking process (see FIG. 13) similar to step S52 (step S602).

  After the first sample acquisition process S602 ends, the CPU 51a sets 1 to the variable i indicating the number of measurements (step S603), and executes the calibrator analysis process (step S604). Since the analysis process of the calibrator is the same as the first sample analysis process described above except that the calibrator is measured instead of the sample, the description thereof is omitted.

  After the calibrator analysis process S604 ends, the CPU 51a determines whether i is 5 or more (step S605). If i is less than 5 (NO in step S605), CPU 51a increments i by 1 (step S606), and returns the process to step S604. Thereby, the calibrator is measured five times by the first measurement unit 2.

When i is 5 or more in step S605 (YES in step S65), the CPU 51a reads the analysis result of the calibrator obtained by the five measurements from the hard disk 51d, and calculates the average value of these analysis results (step S605). In step S607, a correction value is calculated based on the average value and the reference density (step S608). In this process, a correction value is obtained by the following equation.
New correction value = current correction value x (reference concentration / average value of calibrator analysis results)

  Next, the CPU 51a updates the first correction data D1 with this new correction value (step S609). Further, the CPU 51a controls the sample container transport unit 25 to return the sample container T containing the calibrator to the sample rack L (step S610), and returns the processing to the call address for the calibration operation of the first measurement unit 2.

  After the calibration operation of the first measurement unit 2 described above, a post-calibration measurement operation (step S7) is performed. The post-calibration measurement operation will be described in detail below. The post-calibration measurement operation is an operation of measuring the reproducibility check sample after the first measurement unit 2 is calibrated and obtaining the analysis result of the reproducibility check sample. FIG. 16 is a flowchart showing the flow of the post-calibration measurement operation. The CPU 51a controls the sample transport unit 4 so that the sample rack L is transported on the rack transport unit 43, and the holding position 2 of the sample rack L, that is, the sample container T containing the sample for reproducibility confirmation, The sample is again transported to the one sample supply position 43a (step S71). Next, the CPU 51a executes a first sample taking process similar to step S52 (step S72).

  After the first sample take-in process S72 is completed, the CPU 51a executes the first sample analysis process similar to step S54 once (step S73). In the first sample analysis process, the updated first correction data D1 is used to correct the analysis result, and the corrected analysis result is stored in the hard disk 51d.

  Thereafter, the CPU 51a controls the sample container transport unit 25 to return the sample container T containing the sample for reproducibility confirmation to the sample rack L (step S74), and returns the process to the calling address for the post-calibration measurement operation.

  After the post-calibration measurement operation as described above, the calibration operation (step S8) of the second measurement unit 3 is executed. Hereinafter, the calibration operation of the second measurement unit 3 will be described in detail. The calibration operation of the second measurement unit 3 is performed by measuring the sample for reproducibility confirmation before the calibration of the second measurement unit 3 in order to confirm the reproducibility of the analysis result before the calibration of the second measurement unit 3. This is an operation for acquiring the analysis result of the confirmation sample, and an operation for updating the second correction data D2 used for correcting the analysis result obtained from the measurement result by the second measurement unit 3. FIG. 17 is a flowchart showing the flow of the calibration operation of the second measurement unit 3. First, the CPU 51a controls the sample transport unit 4 so that the sample rack L is transported on the rack transport unit 43, and the sample container T holding the sample rack L holding position 2, that is, the sample for reproducibility confirmation, is stored. Then, it is transported to the second sample supply position 43b (step S801).

  Next, the CPU 51a executes a second sample taking process for taking a sample from the sample container T at the second sample supply position 43b into the second measurement unit 3 (step S802). Since the second measurement unit 3 performs the same operation as the first sample acquisition process S52 by the first measurement unit 2 having the same configuration, the second sample acquisition process S802 is omitted.

  After the second sample take-in process S802 is completed, the CPU 51a sets 1 to a variable i indicating the number of measurements (step S803), and executes a second sample analysis process in which the second measurement unit 2 measures the sample (step S803). Step S804). Since the second sample analysis process is the same as the first sample analysis process in step S54 except that the sample is measured by the second measurement unit 3 instead of the first measurement unit 2, the description thereof is omitted. To do.

  After the second sample analysis process S804 ends, the CPU 51a determines whether i is 5 or more (step S805). If i is less than 5 (NO in step S805), CPU 51a increments i by 1 (step S806), and returns the process to step S804. Thereby, the sample for reproducibility confirmation is measured five times by the second measurement unit 3.

  When i is 5 or more in step S805 (YES in step S805), the CPU 51a reads the corrected analysis result of the reproducibility confirmation sample obtained by the five measurements from the hard disk 51d, and displays the five analysis results. It is determined whether or not the variation is within a predetermined range, that is, whether or not the difference between the minimum value and the maximum value of the five analysis results is within the predetermined range (step S807). When the variation of the five analysis results exceeds the predetermined range (NO in step S807), since the second measurement unit 3 is estimated to be abnormal, the CPU 51a displays an abnormality warning screen on the image display unit 52 ( In step S808), the process ends.

On the other hand, when the variation of the five analysis results is within the predetermined range in step S57 (YES in step S807), the CPU 51a calculates the average value of these analysis results (step S809). Further, the CPU 51a reads the analysis result of the sample for reproducibility confirmation by the first measurement unit 2 after the calibration stored in the hard disk 51d in the post-calibration measurement operation S7 from the hard disk 51d, and uses the analysis result as a reference concentration to calculate the average value. A correction value is calculated based on the value and the reference density (step S810). In this process, a correction value is obtained by the following equation.
New correction value = current correction value × (analysis result obtained in S73 / average value of analysis result of sample for reproducibility confirmation by second measurement unit 2)

  Next, the CPU 51a updates the second correction data D2 with this correction value (step S811). Thereafter, the CPU 51a controls the sample container transport unit 25 to return the sample container T containing the sample for reproducibility confirmation to the sample rack L (step S812), and controls the sample transport unit 4 to remove the sample rack L. After the analysis, it is transported to the rack holding unit 42 (step S813), and the process returns to the calling address of the calibration operation of the second measurement unit 3.

  Through the automatic calibration operation as described above, the operator places the sample rack L into which the specimen container T of the calibrator and the specimen container T of the reproducibility confirmation specimen which is a normal specimen are inserted in the pre-analysis rack holding unit 41, The calibration of the first measurement unit 2 and the second measurement unit 3 is automatically performed only by inputting the start instruction of the automatic calibration operation.

<Manual calibration operation>
Next, a manual calibration operation in which the operator or service person manually calibrates the first measurement unit 2 and the second measurement unit 3 will be described. The operator or service person presses the sample setting unit opening / closing button 27 of the first measurement unit 2 to move the sample container setting unit 25b to the priority sample setting position. Thereafter, the operator or service person inserts the sample container T containing the sample for reproducibility confirmation, which is a normal sample, into the sample container setting unit 25b, presses the priority sample measurement start button 28, and performs the sample for reproducibility confirmation. Start measuring. The measurement of the reproducibility confirmation sample by the first measurement unit 2 is performed five times.

  The operator or service person determines whether or not the variation of the five analysis results by the first measurement unit 2 of the sample for reproducibility confirmation obtained in this way is within a predetermined range. Check the reproducibility of the analysis results. The reproducibility of the analysis result of the first measurement unit 2 may be automatically performed by the information processing unit 5 as in the above-described automatic calibration operation.

  After the reproducibility check of the analysis result of the first measurement unit 2 is completed, the operator or service person inserts the sample container T containing the calibrator into the sample container setting unit 25b and presses the priority sample measurement start button 28. The measurement of the reproducibility confirmation sample is started. The measurement of the calibrator by the first measurement unit 2 is performed five times. The operator or service person inputs the reference density of the calibrator to the information processing unit 5. The information processing unit 5 calibrates the first measurement unit 2 by updating the first correction data D1 as in the above-described automatic calibration operation.

  Next, the operator or service person presses the sample setting portion opening / closing button 37 of the second measurement unit 3 to move the sample container setting portion 35b to the priority sample setting position. Thereafter, the operator or service person inserts the sample container T containing the sample for reproducibility confirmation, which is a normal sample, into the sample container setting unit 25b, presses the priority sample measurement start button 28, and performs the sample for reproducibility confirmation. Start measuring. The sample for reproducibility confirmation may be the same sample as the sample for reproducibility confirmation used for the reproducibility check of the first measurement unit 2 or a different sample. The measurement of the sample for reproducibility confirmation by the second measurement unit 3 is performed five times.

  The operator or service person determines whether the variation of the five analysis results by the second measurement unit 3 of the sample for reproducibility confirmation obtained in this way is within a predetermined range. Check the reproducibility of the analysis results.

  After the confirmation of the reproducibility of the analysis result of the second measurement unit 3 is completed, the operator or service person presses the sample setting unit open / close button 27 of the first measurement unit 2, and sets the sample container setting unit 25b to the priority sample setting position. Move. Thereafter, the operator or service person inserts the sample container T containing the sample for reproducibility confirmation used for confirming the reproducibility of the analysis result of the second measurement unit 2 into the sample container setting unit 25b, and performs priority sample measurement. The start button 28 is pressed to start measurement of the reproducibility confirmation sample. The measurement of the reproducibility confirmation sample by the first measurement unit 2 is performed once.

  An operator or a service person performs manual calibration of the second measurement unit 3 after performing each measurement described above. FIG. 18 is a flowchart showing a procedure of manual calibration processing of the second measurement unit 3 by the CPU 51a.

  First, an operator or a service person operates the input unit 53 to give a display instruction for a manual calibration screen to the information processing unit 5. The CPU 51a of the information processing unit 5 displays the manual calibration screen on the image display unit 52 (step S202) when an event for accepting the manual calibration screen display instruction occurs (step S201).

  FIG. 19 is a diagram illustrating an example of a manual calibration screen. The manual calibration screen W includes a list display area A1 that displays a list of a plurality of selected analysis results, an average value display area A2 that displays an average value of the plurality of analysis results for each item, and a target value (reference concentration). Target value display area A3 for displaying for each item, pre-update correction value display area A4 for displaying the pre-update correction value for each item, and post-update correction value display area for displaying the post-update correction value for each item A5 is provided. The manual calibration screen also includes a target value setting button B1 for setting the target value, an OK button B2 for confirming the updated correction value, and the updated correction value is discarded and the correction value is not updated. Cancel button B3 is provided.

  In the list display area A1, measurement date, measurement time, measurement unit used for measurement, and measurement value for each measurement item are displayed. The list display area A1 is provided with 10 rows for displaying the analysis results in order to display 10 analysis results. Next to each analysis result display line, buttons B4, B4,... For calling a dialog (not shown) for searching the analysis result are provided. When the button B4 is selected by operating, the dialog is displayed. An operator or a service person can search the analysis result using this dialog. For example, by inputting a sample ID, measurement date and time, measurement unit, and the like as search keys, a list of corresponding analysis results is displayed. The operator or service person can select a desired analysis result from the list by operating the input unit 53, and when the CPU 51a accepts the selection of such an analysis result (step S203), the CPU 51a The selected analysis result is displayed in the list display area A1 (step S204). At this time, the operator or the service person selects a plurality of analysis results obtained by measuring the same sample with the same measurement unit and having close measurement dates and times. In the present embodiment, a description will be given assuming that five analysis results of the reproducibility confirmation sample by the second measurement unit 3 are selected.

  As shown in FIG. 19, when the above five analysis results are selected, the list display area A1 displays the measurement date, the measurement time, and the device ID of the measurement unit used for the measurement (that is, the second analysis result). The analysis result of each item such as the device ID of the measurement unit 3), WBC, RBC, HGB, PLT, etc. is displayed. The average value display area A2 displays the average value of the analysis results of each item such as WBC, RBC, HGB, PLT, etc., and the correction value display area A4 before update indicates the correction of the current second measurement unit 3. A value is displayed for each item.

  In this state, the operator or service person operates the input unit 53 to select the target value setting button B1. Thus, a target value setting dialog (not shown) is displayed. In this dialog, it is possible to search for an analysis result to be adopted as a target value, and it is also possible to directly input a target value. Using this dialog, the operator or service person selects the analysis result of the reproducibility confirmation sample by the first measurement unit 2 after calibration, and sets this as the target value (step S205). When the CPU 51a accepts this operation, the CPU 51a displays the analysis result of the sample for reproducibility confirmation by the first measurement unit 2 for each item in the target value display area A3. At the same time, the updated correction value is automatically calculated by the CPU 51a (step S206), and the updated correction value is displayed for each item in the updated correction value display area A5.

  The operator or the service person operates the input unit 53 and selects the OK button B2 when the updated correction value displayed is used. When an instruction to update the correction value is given to the CPU 51a (YES in step S207), the CPU 51a changes the second correction data D2 stored in the hard disk 51d to the updated correction value (step S208) and performs manual calibration. The display of the screen W is terminated (step S209), and the process is terminated. Thereby, the calibration of the second measurement unit 3 is completed. On the other hand, the operator or the service person operates the input unit 53 and selects the cancel button B3 when not using the displayed corrected value. When the CPU 51a receives an instruction to cancel the correction value update (NO in step S207), the CPU 51a proceeds to step S209 without updating the second correction data D2 stored in the hard disk 51d. The display of the manual calibration screen W is terminated, and the process is terminated. Thereby, the calibration of the second measurement unit 3 is not performed.

<Sample measurement operation>
Next, the sample measurement operation by the sample analyzer 1 calibrated as described above will be described. In addition, although the measurement operation | movement by the 1st measurement unit 2 is demonstrated here, the measurement operation | movement using the 2nd measurement unit 3 also becomes the same operation | movement. The operator places the sample rack L holding a plurality of sample containers T containing the sample on the pre-analysis rack holding unit 41. In this state, the operator operates the input unit 53 to instruct the information processing unit 5 to execute the sample measurement operation. After receiving the sample measurement operation execution instruction, the information processing unit 5 detects the sample rack L placed on the pre-analysis rack holding unit 41 by a sensor (not shown) and controls the sample transport unit 4 to control the sample rack. L is transferred by the pre-analysis rack holding unit 41, and then the sample rack L is transferred on the rack transfer unit 43, and the sample container T held in the sample rack L is transferred to the first sample supply position 43a.

  FIG. 20 is a flowchart showing the flow of the sample measurement operation for measuring the sample transported to the first sample supply position 43a. The CPU 51a executes a first sample take-in process for taking a sample from the sample container T at the first sample supply position 43a into the first measurement unit 2 (step S301). The first sample taking process S301 is the same as the first sample taking process S52 shown in FIG.

  After the first sample take-in process S301 ends, the CPU 51a executes a first sample analysis process for measuring a sample by the first measurement unit 2 (step S302). In the first sample analysis process S302, the analysis result is corrected by the first correction data D1 updated by the calibration. The first sample analysis process S302 is the same as the first sample analysis process S54 shown in FIG.

  After the completion of the first sample analysis process S302, the CPU 51a controls the sample container transport unit 25 to return the sample container T containing the sample to the sample rack L (step S303), and is obtained by the first sample analysis process S302. The analyzed result is displayed on the image display device 52 (step S304), and the process is terminated. In the analysis result display process S304, an analysis result screen including the analysis result corrected by the updated first correction data D1 is displayed on the image display unit 52.

  Thereafter, the sample rack L is pitch-fed on the rack transport unit 43, and the sample containers T are sequentially transported to the first sample supply position 43a. The sample container T positioned at the first sample supply position 43a is taken into the first measurement unit 2 and analyzed as described above. Such an operation is repeated until the measurement of all samples is completed. Thereby, the sample analysis operation ends.

  In general, when a sample analyzer is calibrated, an arbitrary sample is measured by a measurement unit a plurality of times before the calibration, and the dispersion of analysis results based on each measurement result is within a predetermined range. The reproducibility confirmation of the analysis result for confirming whether it is within the range is performed. Therefore, with the configuration as described above, the first measurement unit 2 is calibrated to calibrate the second measurement unit 3 using the analysis result of the reproducibility confirmation sample by the second measurement unit 3 before calibration. Thus, the second measurement unit can be calibrated simply by measuring the reproducibility confirmation sample. Thereby, it is not necessary to use an expensive calibrator for the calibration of the second measurement unit 3, and it is not necessary to measure the samples unrelated to the calibration with the first measurement unit 2 and the second measurement unit 3, respectively. . For this reason, waste of the specimen, measurement time, and reagent can be reduced.

  In addition, the sample transport unit 4 automatically transports the calibrator and reproducibility confirmation sample, automatically confirms and calibrates the reproducibility of the analysis result of the first measurement unit 2, and reproducibility of the analysis result of the second measurement unit 3. Since it is configured to perform confirmation and calibration, it is possible to reduce the work burden in the reproducibility confirmation and calibration work of the sample analyzer 1 by the operator or service person.

  Further, since the above-described manual calibration operation is possible, the operator or service person selects the analysis result of the past (one day to several days ago) on the manual calibration screen W, thereby calibrating the second measurement unit 3. Therefore, it is not necessary to measure a new specimen. This also can reduce waste of the specimen, measurement time, and reagent.

(Other embodiments)
In the above-described embodiment, after the first measurement unit 2 is calibrated, the sample for reproducibility confirmation is measured by the first measurement unit 2, and the analysis result obtained thereby is used for the calibration of the second measurement unit 3. Although the configuration has been described, the present invention is not limited to this. Before the calibration of the first measurement unit 2, measure the reproducibility confirmation sample used for confirming the reproducibility of the analysis result of the first measurement unit 2 a plurality of times, and average the analysis results before correction obtained at that time, The average value is corrected by the corrected value after calibration of the first measurement unit 2 (that is, the updated first correction data D1), and the analysis result after the correction and the same sample for reproducibility confirmation are subjected to the second measurement. The second measurement unit 3 may be calibrated using the analysis result obtained when the measurement is performed by the unit 3. This eliminates the need to measure the reproducibility confirmation sample by the first measurement unit 2 after the calibration of the first measurement unit 2.

  In the above-described embodiment, in the automatic calibration operation, after the calibration of the first measurement unit 2, the sample for reproducibility confirmation is measured by the first measurement unit 2, and then the reproducibility by the second measurement unit 3. Although the configuration in which the confirmation sample is measured a plurality of times has been described, the configuration is not limited to this. After the calibration of the first measurement unit 2, the second measurement unit 3 may measure the reproducibility confirmation sample a plurality of times, and then the first measurement unit 2 may measure the reproducibility confirmation sample.

  In the above-described embodiment, the number of measurements of the reproducibility confirmation sample in the reproducibility confirmation of the analysis result and the number of measurements of the calibrator in the calibration operation of the first measurement unit 2 are five, but the present invention is not limited to this. It is not something. Other times may be used as long as it is a plurality of times, such as three times, seven times, or ten times. Further, the calibrator may be measured once. Further, the number of measurements of the reproducibility confirmation sample may be different from the number of measurements of the calibrator.

  In the above-described embodiment, the configuration in which all processing of the computer program 54a is executed by the single computer 5a has been described. However, the present invention is not limited to this, and processing similar to that of the computer program 54a described above is performed. It is also possible to make a distributed system in which a plurality of devices (computers) are executed in a distributed manner.

  The sample analyzer of the present invention is useful as a sample analyzer including a plurality of measurement units for measuring a sample, a calibration method for the sample analyzer, and a computer program.

The perspective view which shows the whole structure of the sample analyzer which concerns on embodiment. The perspective view which shows the whole structure of the sample analyzer which concerns on embodiment. The perspective view which shows the external appearance of a sample container. The perspective view which shows the external appearance of a sample rack. The block diagram which shows the structure of the measurement unit which concerns on embodiment. The schematic diagram which shows schematic structure of the optical detection part for WBC / DIFF (white blood cell 5 classification) detection. The top view which shows the structure of a sample conveyance unit. The front view which shows the structure of the 1st belt of a sample conveyance unit. The front view which shows the structure of the 2nd belt of a sample conveyance unit. The block diagram which shows the structure of the information processing unit which concerns on embodiment. The figure which shows the outline of the procedure of the automatic calibration operation | movement of the sample analyzer which concerns on embodiment. The flowchart which shows the flow of a process of CPU of the information processing unit in automatic calibration operation | movement. The flowchart which shows the flow of the reproducibility check process of the 1st measurement unit by CPU of an information processing unit. The flowchart which shows the procedure of the 1st sample taking-in process by CPU of an information processing unit. The flowchart which shows the procedure of the 1st sample analysis process by CPU of an information processing unit. The flowchart which shows the flow of the calibration process of the 1st measurement unit by CPU of an information processing unit. The flowchart which shows the flow of the post-calibration process of the 1st measurement unit by CPU of an information processing unit. The flowchart which shows the flow of the calibration process of the 2nd measurement unit by CPU of an information processing unit. The flowchart which shows the procedure of the manual calibration process of the 2nd measurement unit by CPU of an information processing unit. The figure which shows an example of a manual calibration screen. The flowchart which shows the flow of the sample measurement operation | movement which measures the sample conveyed to the 1st sample supply position.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Sample analyzer 2 1st measurement unit 21 Specimen suction part 22 Sample preparation part 23 Detection part 3 2nd measurement unit 31 Specimen suction part 32 Sample preparation part 33 Detection part 4 Specimen transport unit 41 Pre-analysis rack holding part 42 Post-analysis rack Holding unit 43 Rack transport unit 5 Information processing unit 5a Computer 51a CPU
51b ROM
51c RAM
51d Hard disk 51e Reading device 52 Image display section 53 Input section 54 Portable recording medium 54a Computer program T Sample container L Sample rack D1 First correction data D2 Second correction data W Manual calibration screen A1 List display area A2 Average value display area A3 Target value display area A4 Correction value display area before update A5 Correction value display area after update B1 Target value setting button

Claims (11)

First and second sample measurement units for measuring samples;
An information processing unit that obtains each analysis result based on the measurement of the sample of the first and second sample measurement units,
The information processing unit includes:
First correction means for correcting an analysis result based on measurement of a sample by the first sample measurement unit based on a first correction value;
Second correction means for correcting the analysis result based on the measurement of the sample by the second sample measurement unit based on the second correction value;
First calibration means for updating the first correction value using an analysis result obtained when the first sample measurement unit measures a calibration sample;
The reproducibility check used to determine whether or not the variation of a plurality of analysis results obtained by measuring the same reproducibility check sample a plurality of times by the second sample measurement unit is within a predetermined range. Using a plurality of analysis results and an analysis result after correction obtained by correcting the analysis result based on the measurement by the first sample measurement unit of the sample for reproducibility confirmation with the first correction value updated by the first calibration means Second calibration means for updating the second correction value;
A sample analyzer comprising:   The information processing unit determines whether or not variations in a plurality of analysis results obtained by measuring the reproducibility confirmation sample a plurality of times by the second sample measurement unit are within a predetermined range. The sample analyzer according to claim 1, further comprising a measurement unit reproducibility confirmation unit. A transport unit for transporting the specimen;
In order to supply the reproducibility confirmation sample to the first sample measurement unit and the second sample measurement unit, the reproducibility confirmation sample is transported to the first sample measurement unit and the second sample measurement unit. A transport control means for controlling the transport unit;
Further comprising
The first sample measurement unit is configured to measure the reproducibility confirmation sample transported by the transport unit;
The sample analyzer according to claim 1 or 2, wherein the second sample measurement unit is configured to measure the reproducibility confirmation sample transported by the transport unit a plurality of times. The transport control unit transports the reproducibility confirmation sample to the first sample measurement unit, and after the sample is supplied to the first sample measurement unit, the calibration sample is transferred to the first sample measurement unit. Configured to control the transport unit to transport,
The first sample measurement unit is configured to measure the reproducibility confirmation sample transported by the transport unit a plurality of times, and to measure the calibration sample transported by the transport unit,
The information processing unit determines whether or not variations in a plurality of analysis results obtained by measuring the reproducibility confirmation sample a plurality of times by the first sample measurement unit are within a predetermined range. The sample analyzer according to claim 3, further comprising measurement unit reproducibility confirmation means.   The sample analyzer according to claim 3 or 4, wherein the information processing unit includes the transport control unit. The information processing unit includes storage means for storing a sample analysis result;
Receiving means for receiving selection of a plurality of analysis results of the sample for reproducibility confirmation by the second sample measurement unit from a plurality of analysis results stored in the storage means;
Comprising
The second calibration unit is configured to update the second correction value based on the selected plurality of analysis results and the analysis result of the reproducibility confirmation sample by the first sample measurement unit. The sample analyzer according to any one of claims 1 to 5.   The second calibration means obtains an average value obtained by averaging a plurality of analysis results obtained by the second sample measurement unit measuring the reproducibility confirmation sample a plurality of times, and the first sample measurement unit performs the measurement by the first sample measurement unit. 7. The apparatus according to claim 1, wherein the second correction value is updated based on an analysis result of the reproducibility confirmation sample and an average value of the analysis result by the second sample measurement unit. The sample analyzer described in 1.   The sample analyzer according to claim 1, wherein the information processing unit is configured to output an analysis result corrected by the second correction unit based on the second correction value. A method for calibrating a sample analyzer comprising a first sample measurement unit and a second sample measurement unit,
Obtaining each analysis result based on the measurement of the sample of the first and second sample measurement units;
Correcting the analysis result based on the measurement of the sample by the first sample measurement unit based on the first correction value;
Correcting the analysis result based on the measurement of the sample by the second sample measurement unit based on the second correction value;
Updating the first correction value using an analysis result obtained when the first sample measurement unit measures a calibration sample;
The reproducibility check used to determine whether or not the variation of a plurality of analysis results obtained by measuring the same reproducibility check sample a plurality of times by the second sample measurement unit is within a predetermined range. Using the plurality of analysis results and the corrected analysis result obtained by correcting the analysis result based on the measurement by the first sample measurement unit of the sample for reproducibility confirmation with the updated first correction value, the second correction A method of calibrating the sample analyzer, comprising: updating a value. A method for calibrating a sample analyzer comprising a first sample measurement unit and a second sample measurement unit,
Measuring a calibration sample by the first sample measurement unit and calibrating the first sample measurement unit;
Measuring the same reproducibility confirmation sample a plurality of times by the second sample measurement unit, and determining whether or not variations in the obtained plurality of analysis results are within a predetermined range;
Measuring the reproducibility confirmation sample by the calibrated first sample measurement unit, and obtaining the analysis result of the reproducibility confirmation sample;
Calibrating the second sample measurement unit based on the analysis result of the reproducibility confirmation sample by the first sample measurement unit and the analysis result of the reproducibility confirmation sample by the second sample measurement unit; A method for calibrating a sample analyzer, comprising: A computer program for causing a computer to calibrate a sample analyzer comprising a first sample measurement unit and a second sample measurement unit,
In the computer,
Obtaining each analysis result based on the measurement of the sample of the first and second sample measurement units;
Correcting the analysis result based on the measurement of the sample by the first sample measurement unit based on the first correction value;
Correcting the analysis result based on the measurement of the sample by the second sample measurement unit based on the second correction value;
Updating the first correction value using an analysis result obtained when the first sample measurement unit measures a calibration sample;
The reproducibility check used to determine whether or not the variation of a plurality of analysis results obtained by measuring the same reproducibility check sample a plurality of times by the second sample measurement unit is within a predetermined range. Using the plurality of analysis results and the corrected analysis result obtained by correcting the analysis result based on the measurement by the first sample measurement unit of the sample for reproducibility confirmation with the updated first correction value, the second correction And a step of updating a value.